- Tris Pharma (Monmouth Junction, NJ)
- …success. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager ... and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to... principles in the design (and resolution) of key quality management system elements to ensure complianceTracks… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Suite, Project Management Tools, Ariba or other eSourcing and contracts management systems Self-starter with a proven track record of delivering ... a timely manner and work well with others Certified Professional in Supply Management (CPSM) and/or Certified Purchasing Manager (CPM) a plus. Demonstrated… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …technical solutions including upstream and downstream changes and support Release Manager , system development and testing teams to implement the solution using ... to the Associate Director of Business Applications for Integrated Campaign Management system. The position interacts with multiple NNI internal functions, such… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Management system (CLM) functionality, manages strategic implementation of new procedure/ systems , and is responsible for quality control, including, contract ... as well as projects and processes within the Contract Management function for DSI. Working with and reporting to...point of contact for customer inquiries regarding the process. Manager also handles contract requests, creates and maintains a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... not limited to: Maintain high state of knowledge of the Safety database systems and reporting tools, SOPs, NNI-GS Agreements, FDA safety reporting guidelines and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … management of clinical trial management systems and archiving systems . Relationships Reports to a Manager (or above) within NACD. Manages mutually ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....start up through closure, including but not limited to: Management of clinical trial documents, including but not limited… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management , is accountable for an end-to-end ... on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse...the collection of diverse external data types.Advises Study Data Manager on complex vendor management issues and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …entail working closely with cross functional teams and multiple levels of management . The position will mainly support Emerging pipeline therapeutic areas with ... for pipeline assets. The Emerging Insights and Pipeline Analytics Manager will also work close with data strategy partners...conduct in-depth analytics, working with various data sets and systems leveraged across CI&A, with the ability to deliver… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position To ensure oversight and management of all contract and vendor related activities in Patient Safety including, but not limited to, contract… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …EU preferred)2 or more years Familiarity with pharma and regulatory information management systems (RIMS); Veeva Vault experience preferred. Travel Ability to ... rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global...quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the development and implementation of new processes, procedures and/or systems to improve organizational efficiencies and cost controls.Communication and ... Relationship Management - Leads contract related communication with vendors. Respond...spend category that reduces costs, reduces timelines and improves quality . Coaches and mentors' colleagues on the outsourcing process… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate.-Participate with the identification ... areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensuring quality .Perform all programming tasks required to support Data Management and Biostatistics, as necessary.Perform validation and QC/QA of CDISC, SDTM ... centered around rare diseases and immune disorders. Summary The Manager , Data Programming is a member of the Biostatistics...Programming is a member of the Biostatistics and Data Management team and performs programming tasks, including SDTM and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain effective ... DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …plans.Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems .Company Sponsored Studies (CSS) ... milestones as per contract). Ensure the global clinical operations systems for management of company sponsored studies...and tools to achieve excellence in trial operations and management .Monitor and ensure compliance and highest quality … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …builds and maintains positive relationships with internal/external stakeholders/vendors/partners. - Project Management : Is accountable for quality of delivery in ... quality of external data, transfer standards, and issue management . Ensure consistency of standard implementation across programs. Is...as an extended part of committee. Advise Study Data Manager on complex vendor management issues and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …administration of validated electronic systems such as LMS or other quality management systems .- Strong interpersonal, communication, negotiation and ... units or Global project teams. This position has advanced skills in technology systems , including word processing software and data management software, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …QA, Audit Compliance, Quality Management System [QMS] QA, PV/MA Quality ) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting ... of R&D QA. Within assigned GPTs, facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …trial improvement/innovation projects for NACD & Novo Nordisk (eg, Health Systems , Contract Research Organizations & Site Management Organizations etc.). ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....coordination and communication with CSSAs, CRAs and the Trial Manager (TM) for assigned trials, within the Therapy Area… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …network to influence across the organization.Manages project status in the project management information systems and communicates risks/issues to GPM senior ... project or be partnered with a more senior project manager in support of a larger, more complex drug...drafts stage gate proposals for formal presentation to senior management .Generates and maintains high quality risk … more
